Home IV fluid infusions after radical cystectomy
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial
This trial will test whether giving home IV fluids after radical cystectomy for bladder cancer reduces 90-day hospital readmissions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT07225205 on ClinicalTrials.gov |
What this trial studies
Johns Hopkins is conducting a single-center randomized controlled trial in adults undergoing radical cystectomy for urothelial bladder cancer. Patients are randomized to an Enhanced Recovery After Surgery (ERAS) pathway with a home intravenous fluid program (1 L crystalloid three times per week for four weeks) or ERAS alone. The primary outcome is 90-day hospital readmission, with secondary outcomes including 30- and 90-day complications. Patients with contraindications to home IV therapy or those needing more extensive pelvic exenteration are excluded.
Who should consider this trial
Good fit: Adults (18+) with confirmed urothelial carcinoma who choose to undergo radical cystectomy and have no contraindication to home IV therapy are ideal candidates.
Not a fit: Patients with cardiac, renal, or hepatic dysfunction, those requiring pelvic exenteration, or those unable/unwilling to complete follow-up or receive home infusions are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, adding a home IV program could reduce dehydration-related complications and lower 90-day readmission rates after radical cystectomy.
How similar studies have performed: A prior prospective study suggested a substantial decrease in 90-day readmissions with a home IVF program, but high-quality randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients greater than 18 years of age and older * Confirmed urothelial carcinoma on pathology, including muscle invasive, non-muscle invasive, and variant histology * Patient electing to undergo radical cystectomy with bilateral pelvic lymphadenectomy after counseling with a urologic oncologist. Exclusion Criteria: * Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms) * Patients undergoing radical cystectomy for a non-bladder primary malignancy (e.g. rectal, colon, uterine cancers). * Patients with extensive locally advanced disease necessitating a pelvic exenteration * Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction) * Unwilling or unable to participate in 30 and 90 day follow-up phone calls.
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Max Kates, MD — Johns Hopkins School of Medicine
- Study coordinator: Tyler S Garman, MD
- Email: tgarman1@jhu.edu
- Phone: 410-955-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.